Acromioclavicular JointNCT00840593
A Prospective, Randomised Long-term Follow-up of Operative Versus Non-operative Treatment of Gr. 3 Acromioclavicular Dislocation
A study testing Non-surgical group and Surgical group in people with Acromioclavicular Joint and Dislocation, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acromioclavicular Joint, Dislocation, Surgical Procedures, Operative
- What is being tested?
- Non-surgical group and Surgical group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
- A written informed consent.
Who cannot join
- Not written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.
The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.
Read the detailed description
The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.
There are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.
In this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.
- Being tested
- Non-surgical group, Surgical group
- Keywords
- Acromioclavicular Joint, Dislocation, Trials, Randomized Clinical, Surgical Procedures, Operative
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical groupProcedure or surgery
The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.
Surgical groupProcedure or surgery
The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.
| Study group | Role | What they receive |
|---|---|---|
| 1. Non-surgical group | Active comparator | The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury. Receives: Procedure: Non-surgical group |
| 2 Surgical group | Active comparator | The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group. Receives: Procedure: Surgical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of delayed surgical procedure to treat the AC joint dislocation pathology
Measured: from 18 to 20 years
Secondary outcomes (26)
Grading of the AC dislocation using Rockwood classification (3-6)
Measured: 18-20 years
AC joint width in the middle of the joint (mm)
Measured: 18-20 years
Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)
Measured: 18-20 years
Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs
Measured: 18-20 years
Presence of calcification of CC ligaments (yes/no)
Measured: 18-20 years
Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs
Measured: 18-20 years
Other pathologic condition of the shoulder (eg. osteoarthrosis of the glenohumeral joint, elevation of the humerus, calcific deposits of cuff) and the description of it
Measured: 18-20 years
The source (mechanism) of the AC dislocation injury (eg. falling, collision
Measured: 0 day
Patient age at the time of injury (years)
Measured: 0 day
Patient weight (kg)
Measured: 18 - 20 years
Patient length (cm)
Measured: 18 - 20 years
Occupation
Measured: 18 - 20 years
Grading of the work (light, heavy work, retired)
Measured: 18 - 20 years
Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it
Measured: 18 - 20 years
Larsen score
Measured: 18-20 years
Simple Shoulder Test (SST)
Measured: 18-20 years
UCLA score
Measured: 18-20 years
Constant score
Measured: 18-20 years
Oxford score
Measured: 18-20 years
Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)
Measured: 18-20 years
Pain (VAS, cm) related to instability experience of AC joint
Measured: 18-30 years
Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees
Measured: 18-20 years
Palpation of the AC joint (normal, prominent but stable, unstable)
Measured: 18-20 years
Pain of palpation (no or yes)
Measured: 18-20 years
Cross arm test (pain in AC joint, no/yes)
Measured: 18-20 years
Other pathologic findings of the shoulder in the clinical examination and the description of it
Measured: 18-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Joukainen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840593
- Sponsor's protocol ID
- KUH5203037
- Status last verified
- Dec 2011
- First submitted
- 9 Feb 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.
- ClinicalTrials.gov ID
- NCT00840593
- Acronym / sponsor ID
- KUH5203037
- Keywords
- Acromioclavicular Joint, Dislocation, Trials, Randomized Clinical, Surgical Procedures, Operative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.
Detailed description
The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.
There are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.
In this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Non-surgical group | Active comparator | Procedure: Non-surgical groupThe non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury. |
| 2 Surgical group | Active comparator | Procedure: Surgical groupThe surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
- A written informed consent.
Key exclusion criteria (1 listed)
- Not written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical groupThe non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury. | Procedure or surgery | 1. Non-surgical group |
| Surgical groupThe surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group. | Procedure or surgery | 2 Surgical group |
Primary outcome
Presence of delayed surgical procedure to treat the AC joint dislocation pathology
Time frame: from 18 to 20 years
26 secondary outcomes
Grading of the AC dislocation using Rockwood classification (3-6)
Time frame: 18-20 years
AC joint width in the middle of the joint (mm)
Time frame: 18-20 years
Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)
Time frame: 18-20 years
Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs
Time frame: 18-20 years
Presence of calcification of CC ligaments (yes/no)
Time frame: 18-20 years
Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs
Time frame: 18-20 years
Other pathologic condition of the shoulder (eg. osteoarthrosis of the glenohumeral joint, elevation of the humerus, calcific deposits of cuff) and the description of it
Time frame: 18-20 years
The source (mechanism) of the AC dislocation injury (eg. falling, collision
Time frame: 0 day
Patient age at the time of injury (years)
Time frame: 0 day
Patient weight (kg)
Time frame: 18 - 20 years
Patient length (cm)
Time frame: 18 - 20 years
Occupation
Time frame: 18 - 20 years
Grading of the work (light, heavy work, retired)
Time frame: 18 - 20 years
Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it
Time frame: 18 - 20 years
Larsen score
Time frame: 18-20 years
Simple Shoulder Test (SST)
Time frame: 18-20 years
UCLA score
Time frame: 18-20 years
Constant score
Time frame: 18-20 years
Oxford score
Time frame: 18-20 years
Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)
Time frame: 18-20 years
Pain (VAS, cm) related to instability experience of AC joint
Time frame: 18-30 years
Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees
Time frame: 18-20 years
Palpation of the AC joint (normal, prominent but stable, unstable)
Time frame: 18-20 years
Pain of palpation (no or yes)
Time frame: 18-20 years
Cross arm test (pain in AC joint, no/yes)
Time frame: 18-20 years
Other pathologic findings of the shoulder in the clinical examination and the description of it
Time frame: 18-20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical group and Surgical group in people with Acromioclavicular Joint and Dislocation, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of delayed surgical procedure to treat the AC joint dislocation pathology (time frame: from 18 to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.